CTRI/2024/05/067530尚未招募Unknown
A preliminary investigation of the safety and effectiveness of oral probiotics supplementation for enhancing vaginal health in females with mild to moderate bacterial vaginosis - An open-label, single-arm, prospective interventional proof-of-science study. - Nil
Meteoric Biopharmaceuticals Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.The subject is a healthy non-pregnant/non-lactating females aged 18-55 years.
- •2.Presence of bacterial vaginosis (BV) as determined by gynaecological examination, including assessment for clinical symptoms such as abnormal vaginal discharge, malodour (moderate to very intense), and other relevant clinical indicators.
- •3.The subject is willing to provide written informed consent and follow study procedures.
- •4.The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other intimate wash, lubricant, or treats during the study.
- •5.The subject is willing to use a highly effective method of contraception throughout the clinical investigation. This includes:
- •a.Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- •b.Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration
- •6.Agreement for gynaecological pelvic examination by a Gynaecologist.
- •7.The subject is willing to abstain from sexual intercourse for a period of 24 hours before scheduled study visits to minimize potential interference with study assessments and measurements.
排除标准
- •1.The subject has used hormone replacement therapy in the last 3 months.
- •2.The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections, or urinary tract infections.
- •3.The subject is pregnant/lactating, or are likely to become pregnant.
- •4.The subject has been diagnosed with or reported gynaecologic abnormalities within 60 days prior to study initiation that may influence study results.
- •5.The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
- •6.The subject has chronic infection/allergy/disease that may influence study results.
- •7.The subject has participated in clinical studies or received any investigational agent in the previous 30 days.
- •8.The subject has failed to satisfy the Investigator for fitness to participate for any other reason.
- •9.The subject has not experienced previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
- •10.The subject does not have vaginal prolapse and/or other medical conditions interfering with study conduct and participation.
- •11.The subject has not used systemic and/or local hormonal products for vaginal dryness or any other vaginal condition in the 3 months prior to screening.
研究者
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